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Method and an insertable medical device for delivering one or more pro-healing agents to a target site within a blood vessel post-deployment of a stent

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Method and an insertable medical device for delivering one or more pro-healing agents to a target site within a blood vessel post-deployment of a stent


The invention discloses an insertable medical device for delivering one or more pro-healing agents to a site of deployment of a stent in a blood vessel. The surface of the insertable medical device is coated with nano-carriers that include the one or more pro-healing agents encapsulated with one or more biological agents. The nano-carriers are released when the insertable medical device is expanded at the site. The nano-carriers thus released penetrate tissues at the site resulting in dissolution of the one or more biological agents. Thereafter, the one or more pro-healing agents are released from the nano-carriers at the site. Thus, an in-tissue release of the one or more pro-healing agents at the site is achieved thereby improving endothealisation, extracellular matrix formation and healing at the site post deployment of the stent in the blood vessel.

Browse recent Envision Scientific Private Limited patents - Surate (gujarat), IN
Inventors: Manish Doshi, Divyesh Sherdiwala, Prakash Sojitra
USPTO Applicaton #: #20120277727 - Class: 604509 (USPTO) - 11/01/12 - Class 604 
Surgery > Means For Introducing Or Removing Material From Body For Therapeutic Purposes (e.g., Medicating, Irrigating, Aspirating, Etc.) >Treating Material Introduced Into Or Removed From Body Orifice, Or Inserted Or Removed Subcutaneously Other Than By Diffusing Through Skin >Method >Therapeutic Material Introduced Or Removed Through A Piercing Conduit (e.g., Trocar) Inserted Into Body >Therapeutic Material Introduced Into Or Removed From Vasculature >By Catheter

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The Patent Description & Claims data below is from USPTO Patent Application 20120277727, Method and an insertable medical device for delivering one or more pro-healing agents to a target site within a blood vessel post-deployment of a stent.

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FIELD OF THE INVENTION

The invention relates to a method and an insertable medical device for improving healing of a blood vessel post deployment of a Drug Eluting Stent (DES) in the blood vessel.

BACKGROUND OF THE INVENTION

The current methods of treating blockages in blood vessels include Percutaneous Transluminal Coronary Angioplasty (PTCA). The PTCA includes use of angioplasty balloons, Drug Eluting Stents (DESs) and Bare Metal Stents (BMSs).

In instances where the angioplasty balloons are used for treating the blockages, the inflation of the angioplasty balloons may stretch luminal layers of the blood vessel thereby resulting in inflammation at the site of treatment. The inflammation may further lead to restenosis thereby delaying healing of the blood vessel. In addition to the angioplasty balloons, the BMSs are also used post angioplasty.

The BMSs are generally covered by the tissues of the blood vessel in a timely manner. Thus, proper endothealisation may be achieved in case of the BMSs. However, because of the body\'s immune response to the BMSs and because of the injuries that may occur while deploying the BMSs, instances of inflammations may occur. The inflammations may eventually lead to restenosis.

As compared to the BMSs, the use of the DESs is associated with reduced instances of restenosis. However, the DESs coated on the inner surface with drugs may not allow the tissues of the blood vessel to cover the DESs thereby leading to improper endothealisation and delayed healing. Therefore, the use of the DESs is associated with problems like partial endothealisation and improper formation of extracellular matrix. The partial endothealisation and improper formation of extracellular matrix may further lead to delayed healing of the blood vessel thereby leading to unpredictable outcomes. The unpredictable outcomes may include sub-acute thrombus formation and late catch up that is not observed with the BMSs.

Additionally, the currently used DESs are coated with an anti-proliferative or immunosupressive drugs on an inner surface as well as an outer surface of the DESs. The anti-proliferative or immunosupressive drugs have the property of blocking a proliferation cell cycle of the tissues of the blood vessel. Further, the current DESs employ polymers for loading the drugs on the DESs. The use of polymers results in inflammation at the site of deployment of the DESs. The polymers also lead to complications like, improper coverage of the lesions in the blood vessel, improper release of the drug from the DESs, poor in-tissue drug release and in-tissue drug diffusion, thrombus formation, delayed healing, improper healing, focal restenosis and edge restenosis. The use of the polymers may not facilitate the tissues of the blood vessel to cover the DESs completely and in a timely manner thereby leading to poor endothealisation.

Further, because of the above-mentioned complications associated with the DESs, the patients are often prescribed with a long-term anti-platelet therapy that may extend up to the lifetime of the patient. This post-deployment drug regime has its own side effects and complications.

Therefore, there is a need in the art for an improved method for healing the blood vessels post deployment of the DESs. Further, there is need in the art for a medical device that can improve the performance of the DESs.

BRIEF DESCRIPTION OF FIGURES

FIG. 1 illustrates size distribution of nano-particles of Lipoid E80 as detected by Malvern Zeta Sizer (ZS90) in accordance with Example 1.

FIG. 2 illustrates the size distribution of nano-carriers as detected by Malvern Zeta Sizer (ZS90) in accordance with Example 1.

DETAILED DESCRIPTION

OF THE INVENTION

Before describing in detail embodiments that are in accordance with the invention, it should be observed that the embodiments reside primarily in combinations of components of a nano-carrier eluting catheter balloon and method steps of delivering the nano-carriers for improving healing of a blood vessel post deployment of a stent. Accordingly, the components and the method steps have been described to include only those specific details that are pertinent to understanding the embodiments of the invention so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.

In this document, the terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, or article that comprises a list of elements that does not include only those elements but may include other elements not expressly listed or inherent to such process, method, device or apparatus. An element preceded by “comprises . . . a” does not, without more constraints, preclude the existence of additional identical elements in the process, method, device, or apparatus that comprises the element.

Further, before describing in detail embodiments that are in accordance with the invention, it should be observed that all the scientific and technical terms used in for describing the invention have same meanings as would be understood by a person skilled in the art. The terms “nano-carriers” and “plurality of nano-carriers” have the same meaning in this document unless and until specified otherwise.

Pursuant to various embodiments, the invention discloses an insertable medical device for delivering one or more pro-healing agents to a target site. The target site includes one or more of, but not limited to, a site in the blood vessel where an interventional cardiological procedure, such as, angioplasty or angiography is performed and a site in the blood vessel where a stent is deployed. The stent may include a bare metal stent, a drug-eluting stent, and any endo-luminal stent known in the art. In an embodiment, the stent includes a drug-eluting endovascular stent loaded with one or more drugs using one or more polymers.

The insertable medical device may include a catheter balloon, a diagnostic catheter, an angiography catheter, an endoscopy catheter, and any similar device. In an embodiment, the insertable medical device may be a catheter balloon. The surface of the insertable medical device is coated with a plurality of nano-carriers.

The surface includes one or more of a hydrophilic surface and a non-hydrophilic surface. The hydrophilic surface may include a layer of hydrophilic material, such as, a lubricious coating material, coated on one or more portions of the surface of the insertable medical device. Examples of the lubricious coating material include, but are not limited to, polyalkylene glycols, alkoxy polyalkylene glycols, copolymers of methylvinyl ether and maleic acid poly(vinylpyrrolidone), poly(N-alkylacrylamide), poly(acrylic acid), poly(vinyl alcohol), poly(ethyleneimine), methyl cellulose, carboxymethyl cellulose, polyvinyl sulfonic acid, heparin, dextran, modified dextran and chondroitin sulphate and at least one anti-block agent.

In an embodiment, the surface of the insertable medical device, such as, a catheter balloon has a layer of the lubricious coating material coated on one or more portions of the surface. The surface may further have one or more exposed hydrophilic surfaces. The one or more exposed hydrophilic surfaces may be created at one or more desired portions of the catheter balloon by not coating the plurality of nano-carriers on the one or more desired portions. In an embodiment, the one or more exposed hydrophilic surfaces are created at one or more of one or more portions of a distal end of the hydrophilic surface and one or more portions of a proximal end of the hydrophilic surface.

As such, the one or more exposed hydrophilic surfaces facilitate dissolution of the lubricious coating material upon coming in contact with the blood at the target site. In response to the dissolution of the lubricious coating material, the plurality of nano-carriers are released at the target site from the surface. Thus, the one or more exposed hydrophilic surfaces facilitate the release of the plurality of nano-carriers from the catheter balloon.



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stats Patent Info
Application #
US 20120277727 A1
Publish Date
11/01/2012
Document #
13124125
File Date
01/17/2011
USPTO Class
604509
Other USPTO Classes
60410302
International Class
61M25/10
Drawings
2



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